23/24 June 2021
The U.S. Food and Drug Administration FDA has released a report entitled "Resiliency Roadmap for FDA Inspectional Oversight" that describes the agency's inspection activities during the COVID-19 pandemic. In addition, the document also includes a plan for future inspection improvements and prioritisation.
Review: In March 2020, the FDA announced it would temporarily postpone all domestic and foreign inspections while it continued so-called mission-critical inspections. This report now provides, among other things, an overview of the number of these mission-critical inspections, but also of other approval-related and routine inspections.
The report also describes current activities to resume normal operations of inspection activities, including how FDA intends to prioritize domestic and foreign inspections that were not conducted during the pandemic. There are several possible scenarios here as the course of the pandemic remains uncertain. Prioritization will be risk-based and mission-critical inspections will remain a priority. For less risky facilities, this may lead to delays and longer intervals between inspections.
The FDA is also establishing a so-called FDA Inspectional Affairs Council, which will plan and coordinate inspection activities. More information on this will be provided in due course.